Body pulsating apparatus and method

ABSTRACT

A device and method coupled to a therapy garment to apply pressure and repetitive compression forces to a body of a person has a positive air pulse generator and a user programmable time, frequency and pressure controller operable to regulate the duration of operation, frequency of the air pulses and a selected air pressure applied to the body of a person. The air pulse generator has rigid displacers that are angularly moved with crank power transmissions to draw air into the air pulse generator and discharge air pressure pulses to the therapy garment.

CROSS REFERENCE TO RELATED APPLICATION

None.

FIELD OF THE INVENTION

The invention relates to a medical device operable with a thoracictherapy garment and method to apply repetitive compression forces to thebody of a person to aid blood circulation, loosen and eliminate mucusfrom the lungs and trachea and relieve muscular and nerve tensions.

BACKGROUND OF THE INVENTION

Clearance of mucus from the respiratory tract in healthy individuals isaccomplished primarily by the body's normal mucociliary action andcough. Under normal conditions these mechanisms are very efficient.Impairment of the normal mucociliary transport system or hypersecretionof respiratory mucus results in an accumulation of mucus and debris inthe lungs and can cause severe medical complications such as hypoxemia,hypercapnia, chronic bronchitis and pneumonia. These complications canresult in a diminished quality of life or even become a cause of death.Abnormal respiratory mucus clearance is a manifestation of many medicalconditions such as pertussis, cystic fibrosis, atelectasis,bronchiectasis, cavitating lung disease, vitamin A deficiency, chronicobstructive pulmonary disease, asthma, immotile cilia syndrome andneuromuscular conditions. Exposure to cigarette smoke, air pollutantsand viral infections also adversely affect mucociliary function. Postsurgical patients, paralyzed persons, and newborns with respiratorydistress syndrome also exhibit reduced mucociliary transport.

Chest physiotherapy has had a long history of clinical efficacy and istypically a part of standard medical regimens to enhance respiratorymucus transport. Chest physiotherapy can include mechanical manipulationof the chest, postural drainage with vibration, directed cough, activecycle of breathing and autogenic drainage. External manipulation of thechest and respiratory behavioral training are accepted practices. Thevarious methods of chest physiotherapy to enhance mucus clearance arefrequently combined for optimal efficacy and are prescriptivelyindividualized for each patient by the attending physician.

Cystic fibrosis (CF) is the most common inherited life-threateninggenetic disease among Caucasians. The genetic defect disrupts chloridetransfer in and out of cells, causing the normal mucus from the exocrineglands to become very thick and sticky, eventually blocking ducts of theglands in the pancreas, lungs and liver. Disruption of the pancreaticglands prevents secretion of important digestive enzymes and causesintestinal problems that can lead to malnutrition. In addition, thethick mucus accumulates in the lung's respiratory tracts, causingchronic infections, scarring, and decreased vital capacity. Normalcoughing is not sufficient to dislodge these mucus deposits. CF usuallyappears during the first 10 years of life, often in infancy. Untilrecently, children with CF were not expected to live into their teens.However, with advances in digestive enzyme supplementation,anti-inflammatory therapy, chest physical therapy, and antibiotics, themedian life expectancy has increased to 30 years with some patientsliving into their 50s and beyond. CF is inherited through a recessivegene, meaning that if both parents carry the gene, there is a 25 percentchance that an offspring will have the disease, a 50 percent chance theywill be a carrier and a 25 percent chance they will be geneticallyunaffected. Some individuals who inherit mutated genes from both parentsdo not develop the disease. The normal progression of CF includesgastrointestinal problems, failure to thrive, repeated and multiple lunginfections, and death due to respiratory insufficiency. While somepersons experience grave gastrointestinal symptoms, the majority of CFpersons (90 percent) ultimately succumb to respiratory problems.

Virtually all persons with cystic fibrosis (CF) require respiratorytherapy as a daily part of their care regimen. The buildup of thick,sticky mucus in the lungs clogs airways and traps bacteria, providing anideal environment for respiratory infections and chronic inflammation.This inflammation causes permanent scarring of the lung tissue, reducingthe capacity of the lungs to absorb oxygen and, ultimately, sustainlife. Respiratory therapy must be performed, even when the person isfeeling well, to prevent infections and maintain vital capacity.Traditionally, care providers perform Chest Physical Therapy (CPT) oneto four times per day. CPT consists of a person lying in one of twelvepositions while a caregiver “claps” or pounds on the chest and back overeach lobe of the lung. To treat all areas of the lung in all twelvepositions requires pounding for half to three-quarters of an hour alongwith inhalation therapy. CPT clears the mucus by shaking loose airwaysecretions through chest percussions and draining the loosened mucustoward the mouth. Active coughing is required to ultimately remove theloosened mucus. CPT requires the assistance of a caregiver, often afamily member but a nurse or respiratory therapist if one is notavailable. It is a physically exhausting process for both the CF personand the caregiver. Patient and caregiver non-compliance with prescribedprotocols is a well-recognized problem that renders this methodineffective. CPT effectiveness is also highly technique sensitive anddegrades as the giver becomes tired. The requirement that a secondperson be available to perform the therapy severely limits theindependence of the CF person.

Persons confined to beds and chairs having adverse respiratoryconditions, such as CF and airway clearance therapy, are treated withpressure pulsating devices that subject the person's thorax with highfrequency pressure pulses to assist the lung breathing functions andblood circulation. The pressure pulsating devices are operativelycoupled to thoracic therapy garments adapted to be worn around theperson's upper body. In hospital, medical clinic, and home careapplications, persons require easy application and low cost disposablethoracic garments connectable to portable air pressure pulsating devicesthat can be selectively located adjacent the left or right side of thepersons.

Artificial pressure pulsating devices for applying and relievingpressure on the thorax of a person have been used to assist in lungbreathing functions, and loosening and eliminating mucus from the lungsof CF persons. Subjecting the person's chest and lungs to pressurepulses or vibrations decreases the viscosity of lung and air passagemucus, thereby enhancing fluid mobility and removal from the lungs. Anexample of a body pulsating method and device disclosed by C. N. Hansenin U.S. Pat. No. 6,547,749, incorporated herein by reference, has a caseaccommodating an air pressure and pulse generator. A handle pivotallymounted on the case is used as a hand grip to facilitate transport ofthe generator. The case including the generator must be carried by aperson to different locations to provide treatment to individuals inneed of respiratory therapy. These devices use vests havingair-accommodating bladders that surround the chests of persons. Anexample of a vest used with a body pulsating device is disclosed by C.N. Hansen and L. J. Helgeson in U.S. Pat. No. 6,676,614. The vest isused with an air pressure and pulse generator. Mechanical mechanisms,such as solenoid or motor-operated air valves, bellows and pistons aredisclosed in the prior art to supply air under pressure to diaphragmsand bladders in a regular pattern or pulses. Manually operated controlsare used to adjust the pressure of the air and air pulse frequency foreach person treatment and during the treatment. The bladder worn aroundthe thorax of the CF person repeatedly compresses and releases thethorax at frequencies as high as 25 cycles per second. Each compressionproduces a rush of air through the lobes of the lungs that shears thesecretions from the sides of the airways and propels them toward themouth where they can be removed by normal coughing. Examples of chestcompression medical devices are disclosed in the following U.S. patents.W. J. Warwick and L. G. Hansen in U.S. Pat. Nos. 4,838,263 and 5,056,505disclose a chest compression apparatus having a chest vest surrounding aperson's chest. A motor-driven rotary valve located in a housing locatedon a table allows air to flow into the vest and vent air therefrom toapply pressurized pulses to the person's chest. An alternative pulsepumping system has a pair of bellows connected to a crankshaft with rodsoperated with a dc electric motor. The speed of the motor is regulatedwith a controller to control the frequency of the pressure pulsesapplied to the vest. The patient controls the pressure of the air in thevest by opening and closing the end of an air vent tube. The apparatusmust be carried by a person to different locations to provide treatmentto persons in need of respiratory therapy.

M. Gelfand in U.S. Pat. No. 5,769,800 discloses a vest design for acardiopulmonary resuscitation system having a pneumatic control unitequipped with wheels to allow the control unit to be moved along asupport surface.

N. P. Van Brunt and D. J. Gagne in U.S. Pat. Nos. 5,769,797 and6,036,662 disclose an oscillatory chest compression device having an airpulse generator including a wall with an air chamber and a diaphragmmounted on the wall and exposed to the air chamber. A rod pivotallyconnected to the diaphragm and rotatably connected to a crankshafttransmits force to the diaphragm during rotation of the crankshaft. Anelectric motor drives the crankshaft at selected controlled speeds toregulate the frequency of the air pulses generated by the movingdiaphragm. A blower delivers air to the air chamber to maintain apositive pressure above atmospheric pressure of the air in the chamber.Controls for the motors that move the diaphragm and rotate the blowerare responsive to the air pressure pulses and pressure of the air in theair chamber. These controls have air pulse and air pressure responsivefeedback systems that regulate the operating speeds of the motors tocontrol the pulse frequency and air pressure in the vest. The air pulsegenerator is a mobile unit having a handle and a pair of wheels.

C. N. Hansen in U.S. Pat. No. 6,547,749 also discloses a body pulsatingapparatus having diaphragms operatively connected to a dc motor togenerate air pressure pulses directed to a vest that subjects a person'sbody to high frequency pressure forces. A first manual control operatesto control the speed of the motor to regulate the frequency of the airpressure pulses. A second manual control operates an air flow controlvalve to adjust the pressure of the air directed to the vest therebyregulating the vest pressure on the person's body. An increase ordecrease of the speed of the motor changes the frequency of the airpressure pulses and the vest pressure on the person's body. The secondmanual control must be used by the person or caregiver to adjust thevest pressure to maintain a selected vest pressure.

C. N. Hansen, P. C. Cross and L. H. Helgeson in U.S. Pat. No. 7,537,575discloses a method and apparatus for applying pressure and highfrequency pressure pulses to the upper body of a person. A first userprogrammable memory controls the time of operation of a motor thatoperates the apparatus to control the duration of the supply of airunder pressure and air pressure pulses to a vest located around theupper body of the person. A second user programmable memory controls thespeed of the motor to regulate the frequency of the air pressure pulsesdirected to the vest. A manual operated air flow control valve adjuststhe pressure of air directed to the vest thereby regulating the vestpressure on the person's upper body. An increase or decrease of thespeed of the motor changes the frequency of the air pressure pulses andchanges the vest pressure on the person's upper body. The manuallyoperated air flow control valve must be used by the person or caregiverto maintain a selected vest pressure. The vest pressure is notprogrammed to maintain a selected vest air pressure.

N. P. Van Brunt and M. A. Weber in U.S. Pat. No. 7,121,808 discloses ahigh frequency air pulse generator having an air pulse module with anelectric motor. The module includes first and second diaphragmassemblies driven with a crankshaft operatively connected to theelectric motor. The air pulse module oscillates the air in a sinusoidalwaveform pattern within the air chamber assembly at a selectedfrequency. A steady state air pressure is established in the air chamberwith a blower driven with a separate electric motor. A control boardcarries electronic circuitry for controlling the operation of the airpulse module. Heat dissipating structure is used to maximize the releaseof heat from the heat generated by the electronic circuitry and electricmotors.

SUMMARY OF THE INVENTION

The invention is a medical device and method to deliver high-frequencythoracic wall oscillations to promote airway clearance and improvebronchial drainage in humans. The primary components of the deviceinclude an air pulse generator with user programmable time, frequencyand pressure controls, an air inflatable thoracic garment, and aflexible hose coupling the air pulse generator to the thoracic garmentfor transmitting air pressure and pressure pulses from the air pulsegenerator to the thoracic garment. The air pulse generator has an airdisplacer assembly that provides consistent and positive airdisplacement, air pressure and air flow to the thoracic garment. The airdisplacer assembly has two rigid one-piece members or displacers thatangularly move relative to each other to draw air from an air flowcontrol valve and discharge air pressure pulses at selected frequenciesto the thoracic garment. An alternative air displacer assembly has onerigid one-piece displacer that angularly moves to draw air from an airflow control valve and discharge air pressure pulses at selectedfrequencies to the thoracic garment to subject the thoracic wall of aperson to high-frequency oscillations. Diaphragms and elastic membersare not used in the air displacer assembly. A power drive systemincluding separate eccentric crankshaft power transmissions angularlymove the rigid displacers in opposite directions. These eccentriccrankshafts power transmissions are driven by a variable speed electricmotor regulated with a programmable controller. The air pulse generatoris shown mounted on a portable pedestal having wheels that allow thegenerator to be moved to different locations to provide therapytreatments to a number of persons. The portable pedestal allows the airpulse generator to be located adjacent opposite sides of a personconfined to a bed or chair. The pedestal includes a linear lift thatallows the elevation or height of the air pulse generator to be adjustedto accommodate different locations and persons. The thoracic therapygarment has an elongated flexible bladder or air core having one or aplurality of elongated generally parallel chambers for accommodatingair. An air inlet connector joined to a lower portion of the air core isreleasably coupled to a flexible hose joined to the air pulse outlet ofthe air pulse generator. The thoracic therapy garment may be reversiblewith a single air inlet connector that can be accessed from either sideof a person's bed or chair. The air pulse generator includes a housingsupporting air pulse generator controls for convenient use. The airpulse generator controls include a control panel having user interactivecontrols for activating an electronic memory program to regulate thetime or duration of operation of the air pulse generator, the frequencyof the air pulses and the pressure of the air pulses directed to thetherapy garment. The pressure of the air established by the airpulse-generator is coordinated with the frequency of the air pulseswhereby the air pressure is substantially maintained at a selectedpressure when the pulse frequency is changed.

DESCRIPTION OF THE DRAWING

FIG. 1 is a perspective view of a thoracic therapy garment locatedaround the thorax of a person connected with a hose to a pedestalmounted air pulse generator;

FIG. 2 is a front elevational view, partly sectioned, of the thoracictherapy garment of FIG. 1 located around the thorax of a person;

FIG. 3 is an enlarged sectional view of the right side of the thoracictherapy garment of FIG. 2 on the thorax of a person;

FIG. 4 is a diagram of the user programmable control system for the airpulse generator of FIG. 1;

FIG. 5 is a top plan view of the air pulse generator;

FIG. 6 is a front elevational view of the air pulse generator shown inFIG. 5;

FIG. 7 is an end elevational view of the right end of the air pulsegenerator shown in FIG. 5;

FIG. 8 is an end elevational view of the left end of the air pulsegenerator shown in FIG. 5;

FIG. 9 is a sectional view taken along line 9-9 of FIG. 6;

FIG. 10 is a perspective view of the air pulse displacer assembly of theair pulse generator of FIG. 5;

FIG. 11 is a sectional view taken along line 11-11 of FIG. 9;

FIG. 12 is an enlarged sectional view taken along line 12-12 of FIG. 9;

FIG. 13 is a perspective view of the air pulse generator of FIG. 5 withparts of the housing removed;

FIG. 14 is a perspective view taken along line 14-14 of FIG. 9;

FIG. 15 is a sectional view taken along the line 15-15 of FIG. 5 showingthe air pulse displacer assembly in the closed position;

FIG. 16 is a sectional view similar to FIG. 15 showing the air pulsedisplacer assembly in the open position;

FIG. 17 is a perspective view of an alternative power transmissionassembly for rotating the crankshafts that angularly move the displacersof the air pulse displacer assembly; and

FIG. 18 is a right end elevational view of the power transmissionassembly of FIG. 17.

DESCRIPTION OF INVENTION

A human body pulsing apparatus 10 for applying high frequency pressurepulses to the thoracic wall of a person, shown in FIG. 1, comprises anair pulse generator 11 having a housing 12. A movable pedestal 29supports generator 11 and housing 12 on a surface, such as a floor.Pedestal 29 allows respiratory therapists and patient care persons totransport the entire human body pulsating apparatus to differentlocations accommodating a number of persons in need of respiratorytherapy and to storage locations. Air pulse generator 11 can beseparated from pedestal 29 and used to provide respiratory therapy toportions of a person's body.

Human body pulsing apparatus 10 is a device used with a thoracic therapygarment 30 to apply pressure and repetitive high frequencies pressurepulses to a person's thorax to provide secretion and mucus clearancetherapy. Respiratory mucus clearance is applicable to many medicalconditions, such as pertussis, cystic fibrosis, atelectasis,bronchiectasis, cavitating lung disease, vitamin A deficiency, chronicobstructive pulmonary disease, asthma, and immobile cilia syndrome. Postsurgical patients, paralyzed persons, and newborns with respiratorydistress syndrome have reduced mucociliary transport. Air pulsegenerator 11 through hose 61 provides high frequency chest walloscillations or pulses to a person's thorax enhance mucus and airwayclearance in a person with reduced mucociliary transport. High frequencypressure pulses subjected to the thorax in addition to providingrespiratory therapy to a person's lungs and trachea.

As shown in FIGS. 1 and 4, housing 12 is a generally rectangular memberhaving a front wall 13 and side walls 26 and 27 joined to a top wall 16.An arched member 17 having a horizontal handle 18 extended over top wall16 is joined to opposite portions of top wall 16 whereby handle 18 canbe used to manually carry air pulse generator 11 and facilitate mountingair pulse generator 11 on pedestal 29. A control panel 23 mounted on topwall 16 has interactive controls 24 to program time, frequency andpressure of air directed to the therapy garment 30. Other controldevices including switches and dials can be used to program time,frequency and pressure of air transmitted to therapy garment 30. Thecontrols 24 are readily accessible by the respiratory therapists anduser of pulsing apparatus 10.

Private care homes, assisted living facilities and clinics canaccommodate a number of persons in different rooms or locations thatrequire respiratory therapy or high frequency chest wall oscillations asmedical treatments. Air pulse generator 11 can be manually moved torequired locations and connected with a flexible hose 61 to a thoracictherapy garment 30 located around a person's thorax. Air pulse generator11 can be selectively located adjacent the left or right side of aperson 60 who may be confined to a bed or chair.

Pedestal 29 has an upright gas operated piston and cylinder assembly 31mounted on a base 32 having outwardly extended legs 33, 34, 35, 36 and37. Other types of linear expandable and contractible devices can beused to change the location of generator 11. Caster wheels 38 arepivotally mounted on the outer ends of legs 33-37 to facilitate movementof body pulsating apparatus 10 along a support surface. One or morewheels 38 are provided with releasable brakes to hold apparatus 10 in afixed location. An example of a pedestal is disclosed by L. J. Helgesonand Michael W. Larson in U.S. Pat. No. 7,713,219, incorporated herein byreference. Piston and cylinder assembly 31 is linearly extendable toelevate air pulsator 10 to a height convenient to the respiratorytherapist or user. A gas control valve having a foot operated ring lever39 is used to regulate the linear extension of piston and cylinderassembly 31 and resultant elevation of pulsator 10. Air pulse generator11 can be located in positions between its up and down positions. Lever39 and gas control valve are operative associated with the lower end ofpiston and cylinder assembly 31.

A frame assembly 41 having parallel horizontal members 42 and 43 and aplatform 44 mounts housing 12 on top of upright piston and cylinderassembly 31. The upper member of piston and cylinder assembly 31 issecured to the middle of platform 44. The opposite ends 46 of platform44 are turned down over horizontal members 42 and 43 and secured theretowith fasteners 48. Upright inverted U-shaped arms 51 and 52 joined toopposite ends of horizontal members 42 and 43 are located adjacentopposite side walls 26 and 27 of housing 12. U-shaped handles 56 and 57are joined to and extend outwardly from arms 51 and 52 provide handgrips to facilitate manual movement of the air pulse generator 11 andpedestal 29 on a floor or carpet. An electrical female receptacle 58mounted on side wall 27 faces the area surrounded by arm 51 so that arm51 protects the male plug (not shown) that fits into receptacle 58 toprovide electric power to air pulse generator 11. A tubular air outletsleeve is mounted on side wall 26 of housing 12. Hose 61 leading tothoracic therapy garment 30 telescopes into the sleeve to allow air, airpressure and air pulses to travel through hose 61 to thoracic therapygarment 30 to apply pressure and pulses to a person's body.

Thoracic therapy garment 30, shown in FIG. 3, is located around theperson's thoracic wall 69 in substantial surface contact with the entirecircumference of thoracic wall 69. Garment 30 includes an air core 35having one or more enclosed chambers 40 for accommodating air pulses andair under pressure. The pressure of the air in the chambers retainsgarment 30 in firm contact with thoracic wall 69. Air core 35 has aplurality of holes that vent air from chambers 40. Thoracic therapygarment 30 functions to apply repeated high frequency compression orpressure pulses, shown by arrows 71 and 72, to the person's lungs 66 and67 and trachea 68. The reaction of lungs 66 and 67 and trachea 68 to thepressure pulses causes repetitive expansion and contraction of the lungtissue resulting in secretions and mucus clearance therapy. The thoraciccavity occupies only the upper part of the thoracic cage which containslungs 66 and 67, heart 62, arteries 63 and 64, and rib cage 70. Rib cage70 also aids in the distribution of the pressure pulses to lungs 66 and67 and trachea 68.

As shown in FIG. 4, air pulse generator 11 has a case 100 located withinhousing 12. An electric motor 101 mounted on case 100 operates tocontrol the time duration and frequency of the air pulses produced bygenerator 11 and directed to garment 30. A sensor 102, such as a Halleffect sensor, is used to generate a signal representing the rotationalspeed of motor 101. A motor speed control regulator 103 wired with anelectric cable 104 to motor 101 controls the operating speed of motor101. An electric power source 105 wired to motor speed control regulator103 supplies electric power to regulator 30 which controls the electricpower to electric motor 101. The electric power source can beconventional grid electric power and/or a battery. Other devices can beused to determine the speed of motor 101 and provide speed data tocontroller 106. A sensor-less commutation control of a 3-phase dc motorcan be used to control the rotational speed of motor 101. A controller106 having user programmable controls with memory components and alook-up data table wired with an electric cable 107 to motor speedcontrol regulator 103 controls the time of operation of motor 101, thespeed of motor 101 and the pressure of air directed to garment 30 shownby arrow 143. The signal generated by sensor 102 is transmitted by cable108 to controller's look-up data table that coordinates the speed ofmotor 101 and resulting frequency of the air pulse with a selected airpressure to maintain a selected air pressure when the speed of motor 101and frequency of the air pulses are changed. The look-up table is anarray of digital data of the speed of motor 101 and air pressurescreated by the air pulse generator predetermined and stored in a staticprogram storage which is initialized by changes in the speed of motor101 to provide an output to stepper motor 126 to regulate air flowcontrol member 122 to maintain a preset or selected air pressure createdby air pulse generator 11. The look up table may include identifyingalgorithms designed to take several data inputs and extrapolate areasoned response.

Screen 24 of control panel 23 may have three user interactive controls109, 110 and 111. Control 109 is a time or duration of operation ofmotor 101. For example, the time can be selected from 0 to 30 minutes.Control 110 is a motor speed regulator to control the air pulsefrequency for example between 5 and 20 cycles per second or Hz. A changeof the air pulse frequency results in either an increase or decrease ofthe air pressure in garment 30. The pressure of the air in garment 30 isselected with the use of average or bias air pressure control 111. Thechanges of the time, frequency and pressure may be manually altered byapplying finger pressure along the controls 109, 110 and 111. Controlpanel may include a start symbol 112 operable to connect air pulsegenerator 11 to an external electric power source. Set and home symbols113 and 114 may be used to embed the selected time, frequency, andpressure in the memory data of controller 106. A cable 116 wirescontroller 106 with control panel 23. One or more cables 117 wirecontrol panel 23 to controller 106 whereby the time, frequency andpressure signals generated by slider controls 109, 110 and 111 aretransmitted to controller 106. Other types of panels and devices,including tactile switches in the form of resistive or capacitivetechnologies and dials can be used to provide user input to controller106.

The air pressure in garment 30 is regulated with a first member shown asa proportional air flow control valve 118 having a variable orificeoperable to restrict or choke the flow of air into and out of air pulsegenerator 11. Valve 118 has a body 119 having a first passage 121 toallow air to flow through body 119. An air flow control member orrestrictor 122 having an end extended into the first passage regulatesthe flow of air through passage 121 into tube 131. Body 119 has a secondair bypass passage 123 that allows a limited amount of air to flow intotube 131. The air in passage 123 bypasses air flow restrictor 122whereby a minimum amount of air flows into air pulse generator 11 sothat the minimum therapy treatment will not go down to zero. A filter124 connected to the air inlet end of body 119 filters and allowsambient air to flow into and out of valve 118. Air flow restrictor 122is regulated with a second member shown as a stepper motor 126. Steppermotor 126 has natural set index points called steps that remain fixedwhen there is no electric power applied to motor 126. Stepper motor 126is wired with a cable 127 to controller 106 which controls the operationof motor 126. An example of a stepper motor controlled metering valve isdisclosed by G. Sing and A. J. Horne in U.S. Patent ApplicationPublication No. US 2010/0288364. The stepper motor control is describedby L. J. Helgeson and M. W. Larson in U.S. Provisional PatentApplication Ser. No. 61/573,238, incorporated herein by reference. Othertypes of air flow meters having electronic controls, such as a solenoidcontrol valve, a rotatable grooved ball valve or a movable disk valve,can be used to regulate the air flow to air pulse generator 11. Anorifice member 128 has a longitudinal passage 129 located in tube 131.Orifice member 128 limits the maximum air flow into and out of air pulsegenerator 11 to prevent excessive air pressure in garment 30.

As shown in FIGS. 5 to 9, 11 and 13, air pulse generator housing 100 hasa front wall 132 and a rear wall 133 with first pumping chambers 137 and140 between walls 132 and 133. An interior wall 134 and end wall 136attached to opposite ends of walls 132 and 133 enclose chambers 137 and140. As seen in FIG. 14, interior wall 134 has a plurality of passages138 and 139 to allow air to flow from chamber 148 into chambers 137 and140. Wall 134 can have additional passages, openings or holes to allowair to flow from chamber 148 into chambers 137 and 140. End wall 136 hasan outwardly projected tubular boss 141 having a passage 142 to allowair, shown by arrow 143, to flow out of air pulse generator 11 into hose61 and to garment 30. The frequency of the air flow pulses is regulatedby varying the operating speed of motor 101. Air flow control valve 118largely regulates the pressure of the air discharged from the air pulsegenerator 11 to garment 30.

A second housing 144 joined to adjacent interior wall 134 accommodates acover 146 enclosing a manifold chamber 148, shown in FIGS. 9 and 13. Aplurality of fasteners 147 secure housing 144 and cover 146 to interiorwall 134. A tubular connector 149 mounted on cover 146 and connected totube 131 allows air to flow from air flow restrictor valve 118 intomanifold chamber 148. Passages 138 and 139 are open to manifold chamber148 and pumping chambers 137 and 140 to allow air to flow from manifoldchamber 148 into pumping chambers 137 and 140.

As shown in FIGS. 9 and 10, an air displacer assembly 151 operates todraw air into pumping chambers 137 and 140. Air displacer assembly 151has two rigid air displacers 152 and 153 operable to swing or pivotbetween first and second positions to pump and pulse air directed togarment 30. The air displacer assembly may be a single displaceroperable to pivot between first and second positions to provide airpressure pulses to garment 30. The single displacer includes thestructures and functions of displacer 152 angularly moved with powertransmission 179. The opposite sides of rear section 159 of displacer152 have outwardly extended axles or pins 154 and 156. Pin 154 isrotatably mounted with a bearing 157 on end wall 136. Pin 156 isrotatably mounted on interior wall 134 with a bearing 158. A singlepivot member may be used to pivotally mount displacer 152 on housing100. Displacer 152 is a rigid member that does not change its geometricshape when pivoting about the fixed transverse axis between the open andclosed positions, shown in FIGS. 15 and 16. Displacer 152 has agenerally rectangular shape with a transverse rear ridge 159 and asemi-cylindrical front section 161. A generally flat middle section 162joins rear ridge 159 to front section 161. The entire outer peripheryhas a recess or groove 165 accommodating a seal assembly 163. As shownin FIG. 12, groove 165 has a rectangular shape open to the outer end ofouter section 161 of displacer 152. Rear ridge 159 and middle section162 of displacer 152 each have a groove 165 for retaining seal assembly163. As shown in FIG. 12, seal assembly 163 has a rigid component rib164 and low density elastic foam component 169. Seal assembly 163comprises a high density polymer rib 164 partly located in groove 165.The outer surface of rib 164 is in sliding engagement with the insidesurface 166 of wall 134. There is also sliding engagement of rib 164with the concave curved inside surfaces 167 and 168 of walls 132 and133, as shown in FIGS. 11 and 14. Returning to FIG. 9, seal assembly 163is in sliding engagement with the inside surfaces of walls 132, 133, 134and 136. Returning to FIG. 12, the foam component of seal assembly 163is a close cell elastomeric foam material spring 169 located in the baseof groove 165. The spring 169 forces rib 164 into sealing engagementwith surface 166 of wall 134. The biasing force of foam material spring169 also compensates for structural tolerances and wear of rib 164.Other types of seals and spring biasing forces can be used withdisplacer 152 to engage walls 132, 133, 134 and 136.

As shown in FIG. 11, the middle section 162 of displacer 152 has aplurality of holes 171 providing openings that allow air to flow, shownby arrow 176, from chamber 137 to pulsing chamber 177 located betweendisplacers 152 and 153. A check valve 172 mounted on middle section 162allows air to flow from chamber 137 to chamber 177 and prevents the flowof air from chamber 177 back to chamber 137. Check valve 172 is aone-piece flexible member having a stem 173 pressed into a hole inmiddle section 162 and an annular flexible flange 174 covering thebottoms of holes 171 to prevent the flow of air from chamber 177 back tochamber 137 when the pressure of the air in chamber 177 is higher thanthe air pressure in chambers 137, 140 and 148. Other types and locationsof check valves can be used to control the flow of air from chambers 137and 140 into chamber 148.

As shown in FIGS. 9, 10 and 11, the power drive system includes ananti-backlash device operable without lost motion to angularly move thefirst and second displacers between first and second positions. Theanti-backlash device comprises an arm 178 located above middle section162 of displacer 152. A first end of arm 178 is pivotally connected to asupport 179 with a pivot pin 181. Support 179 is fastened to the rearsection 159 of displacer 152. The pivot axis of pin 181 is parallel withthe pivot axis of pins 154 and 156. The second or front end 182 of arm178 extends in a downward direction toward the top of middle section 162adjacent the semi-cylindrical section 161. Front end 182 has an uprightrecess 183 and a bottom wall 184 spaced above the top of middle section162 of displacer 152. An upright bolt 186 located within recess 183 andextended through bottom wall 184 is threaded into a hole 188 in middlesection 162 of displacer 152. A coil spring 187 located between the headof bolt 186 and bottom wall 184 of arm 178 biases and pivots arm 178toward the top of displacer 152. Arm 178 and coil spring 187 providecrankshaft 189 with anti-backlash functions and compensate for wear andthermal expansion. Arm 178 cooperates with a power transmissionmechanism 179 to pivot air displacer 152 for angular movement betweenopen and closed positions.

Power transmission mechanism 189 is operatively associated withdisplacer 152 and arm 178 to angularly move displacer 152 toward andaway from displacer 153 to draw air into chamber 137 and compress andpulse air in chamber 177. Power transmission mechanism is a crankshafthaving a shaft 191 with one end rotatably mounted on end plate 136 witha bearing 192. The opposite end of shaft 191 is rotatably mounted oninterior plate 134 with a bearing 193. Other structures can be used torotatably mount shaft 191 on housing walls 134 and 136. Crankshaftincludes a crank pin 194 offset from the axis of rotation of shaft 191.A first pair of cylindrical roller members 196 rotatable mounted oncrank pin 194 engage a first pad 197 retained in a recess in middlesection 162 of displacer 152. A second pair of cylindrical rollermembers 198 rotatably mounted on crank pin 194 engage a second pad 199retained in a recess in middle section 162 of displacer 152. Rollermembers 196 and 198 are axially spaced on opposite sides of arm 178. Asseen in FIG. 10, a roller member 201 rotatably mounted on the middle ofcrank pin 194 engages the bottom surface 202 of arm 178. Roller member201 is spaced above the top of displacer 152. Rotation of shaft 191moves crank pin 194 in a circular path whereby rollers members 196 and198 angularly moves displacer 152 downwardly to the closed position androller member 201 angularly moves displacer 152 upwardly to the openposition. Spring 187 maintains arm 178 in continuous engagement withroller member 201 and creates reaction forces on pads 197 and 199through roller members 196 and 198 thereby eliminating clearance,backlash or lost motion between arm 178 and roller member 201.

Displacer 153 has the same structure as displacer 152. Axles or pins 203pivotally mount the rear section of displacer 153. The axial axis ofpins 203 is parallel to the axial axis of pins 154 and 156. The entireouter peripheral edges of displacer 153 has a seal 204 located inengagement with curved surfaces 206 and 207 of housing 101 as shown inFIGS. 15 and 16 and the inside surfaces of plates 134 and 136. Seal 204has the same rib and spring as seal 163 shown in FIG. 12. The middlesection of displacer 153 has holes associated with a check valve 208 toallow air to flow from chamber 140 into air pulse chamber 177 andprevent the air in chamber 177 from flowing back to chamber 140. Checkvalve 208 has the same stem and annular flexible flange as check valve172 shown in FIG. 11. An arm 209 pivotally connected to a support 211secured to the rear section of displacer 153 is operatively associatedwith a power transmission assembly 212. Power transmission assembly 212operates to angularly move displacer 153 between closed and openpositions as shown in FIGS. 15 and 16. Power transmission assembly 212is a crankshaft having a shaft 213 and roller members 214 engaging pads216 mounted on displacer 153. Power transmission assembly 212 has thesame structure as power transmission assembly 189. A check valve 208mounted on displacer 153 controls the flow of air form chamber 140 tochamber 142 and prevents the flow of air from chamber 142 back tochamber 140. Check valve 208 has the same structure as check valve 172shown in FIG. 11.

As shown in FIGS. 15 and 16, power transmission assemblies 189 and 212are driven in opposite rotational directions with a power train assembly217. Power train assembly 217, driven by electric motor 101, has a firstbelt drive comprising a timing pulley 218 drivably connected to motor101. Timing pulley 218 accommodates an endless tooth belt 219 trainedaround a driven tooth timing pulley 221. A second belt drive powered bypulley 221 rotates a first pulley 222 connected to shaft 191 and asecond pulley 223 connected to shaft 213 in opposite directions as shownby arrows 224 and 226. The second belt drive operates power transmissionassemblies 189 and 212 to turn their respective crankshafts in oppositerotational directions to concurrently angularly move displacers 152 and153 to open and closed positions shown in FIGS. 15 and 16 therebypulsing air in chamber 177. Pulley 227 driven by pulley 221 accommodatesan endless serpentine double-sided tooth belt 228 that rides on idlerpulleys 229 and 231 and trains about opposite arcuate segments ofpulleys 222 and 223. The entire power train assembly 217 is locatedwithin chamber 148 of second housing 144. The power train assembly 217and power transmission assemblies comprise a power drive system operableto angularly move the air displacers 152 and 153 to open and closedpositions to cause air to flow from pumping chambers 137 and 140 intopulsing chamber 177 and direct air pressure pulses out of pulsingchamber 177 into hose 61 and garment 30.

In use, as shown in FIGS. 1 to 3, garment 30 is placed about theperson's upper body or thoracic wall 69. The circumferential portion ofgarment 30 includes an air core 35 having one or more internal chambers40 that is maintained in a comfortable snug fit on thoracic wall 69. Theelongated flexible hose 61 is connected to air core 35 and air pulsegenerator 11. Operation of air pulse generator 11 discharges air underpressure and high frequency air pressure pulses into hose 61 which aretransferred to the internal chamber 40 of air core 35. As shown in FIGS.2 and 3, high frequency pressure pulses 72 are transmitted from air core35 to the person's thoracic wall 69 thereby subjecting the person'sthoracic wall 69 to respiratory therapy. The person 60 or a care personsets the time, frequency and pressure controls 109, 110, 111 associatedwith control panel 23 to program the duration of operation of air pulsegenerator 11, the frequency of the air pressure pulses and the pressureof the air created by air pulse generator 11. The time program controlsthe operation of motor 101 that operates air displacers 152 and 153. Asshown in FIGS. 15 and 16, air displacers 152 and 153 angularly pivotrelative to each other between open first positions to closed secondpositions. Air displacers 152 and 153 draw air into pumping chambers 137and 140. The flow of air into pumping chambers 137 and 140 is regulatedwith air flow control valve 118. Adjustment of air flow control valve118 with stepper motor 126 controls the pressure of the air dischargedby generator 11 to air core 35 of garment 30. The flow of air intochamber 148 is limited by air flow orifice member 128 to control maximumair flow into chamber 148 and prevents excessive air pressure in garment30. The air in pumping chambers 137 and 140 is forced through checkvalves 172 and 208 into pulsing chamber 177 located between airdisplacers 152 and 153. Angular movements of air displacers 152 and 153toward each other pulses the air in pulsing chamber 177 and dischargesair and air pulses through air outlet passage 142 into hose 61. Hose 61transports air and air pulses to air core 35 of garment 30 therebysubjecting the person's thorax to pressure and high frequency pressurepulses.

As shown in FIG. 13, motor 101 drives power transmission assembly 217 torotate crankshafts 189 and 212 to concurrently angularly pivot airdisplacers 152 and 153 between open and closed positions. Arms 178 and208 pivotally mounted air displacers 152 and 153 cooperate withcrankshafts 189 and 212 to limit the angular movement of air displacers152 and 153. The outer ends of arms 178 and 208 support coil springs 187that provide crankshafts 189 and 212 with anti-lash functions andcompensate for wear and thermal expansion.

A modification of the air pulse generator 300, shown in FIGS. 17 and 18,is operable to establish air pressure and air pulses which are directedby hose 61 to garment 30 to apply repetitive forces to the thoracic wallof a person. Air pulse generator 300 has a housing including end walls301 and 302. A displacer assembly 303 located between end walls 301 and302 has a pair of displacers 304 and 306 pivotally mounted on end walls301 and 302 for angular movements relative to each other to draw airfrom a manifold chamber 308 into air pumping chambers 312 and 313. Theair in pumping chambers 312 and 313 flows through check valves mountedon displacers 304 and 306 into a pulsing chamber 315 located betweendisplacers 304 and 306. Displacers 304 and 305 have the same structureand functions as displacers 152 and 153 shown in FIGS. 9, 15 and 16which are incorporated herein by reference. As shown in FIG. 18,displacer 304 has an axle or pin 316 retained in a bearing 317 mountedin a cylindrical boss 318 joined to end wall 302. The opposite side ofdisplacer 304 has an axle or pin rotatable mounted on end wall 301.Displacer 316 located below displacer 304 has an axle or pin 319retained in a bearing 321 mounted in a cylindrical boss 322 joined toend wall 302. Displacers 304 and 306 angularly move relative to eachother about laterally spaced parallel horizontal axes of pins 316 and319. A housing or casing 302 joined to end wall 307 surrounds manifoldchamber 308. A cover with an air inlet tubular member (not shown)attached to housing 307 encloses manifold chamber 308. End wall 302,shown in FIG. 18, has passages or openings 309, 310 and 311 to air toflow from manifold chamber 308 into pumping chambers 312 and 313.Crankshafts 314 and 320 are power transmission mechanisms that operateto angularly move displacers 304 and 305 in opposite arcuate directionsto draw air from chamber 308 through openings 309, 310 and 311 and intopumping chambers 312 and 313 and pulse air in pulsing chamber 315whereby air pressure and air pulses are directed by hose 61 to garment30.

A power transmission assembly 323 driven with an electric motor 324rotates crankshafts 314 and 320 whereby the crankshafts concurrentlyangularly move displacers 304 and 306. Power transmission assembly 323has a first power train 326 driving a second power train 327 thatrotates crankshafts 314 and 320. First power train 326 has a drivetiming pulley 328 mounted on motor drive shaft 329 engageable with anendless tooth belt 331 located around a driven timing pulley 332. Pulley332 is secured to a shaft 333 retained in a bearing 334 mounted on afixed support 336. Support 336 is attached to housing 307 with fasteners337 and 338. Second power train 329 has a drive timing pulley 339mounted on shaft 333. A bearing 334 holds shaft 333 on support 336. Belt341 extended around timing pulleys 339, 342 and 343 rotates pulleys 342and 343 mounted on crankshafts 314 and 320 thereby rotating crankshafts314 and 320 and angularly moving displacers 304 and 306 relative to eachother. The movement of displacers 304 and 306 draws air into manifoldchamber 308 and through openings 309 and 311 into pumping chambers 312and 313. When the air pressure in pumping chambers 312 and 313 isgreater than the air pressure in pulsing chamber 315, the air flowsthrough the check valves from pumping chambers 312 and 313 into pulsingchamber 315. When the displacers 304 and 306 move toward each other, airpressure and air pulses are forced into hose 61 and carried by hose 61to the air core 35 of garment 30. The air pressure and air pulses in aircore 35 of garment 30 subjects the thoracic wall of the person withrepetitive forces.

The body pulsing apparatus and method has been described as applicableto persons having cystic fibrosis. The body pulsing apparatus and methodis applicable to bronchiectasis persons, post-surgical atelectasis, andstage neuromuscular disease, ventilator dependent patients experiencingfrequent pneumonias, and persons with reduced mobility or poor toleranceof Trendelenburg position. Person with secretion clearance problemsarising from a broad range of diseases and conditions are candidates fortherapy using the body pulsating apparatus and method of the invention.

The body pulsating apparatus and method disclosed herein has one or moreangularly movable air displacers and programmed controls for the time,frequency and pressure operation of the air pulse generator and method.It is understood that the body pulsating apparatus and method is notlimited to specific materials, construction, arrangements and method ofoperation as shown and described. Changes in parts, size of parts,materials, arrangement and locations of structures may be made bypersons skilled in the art without departing from the invention.

1. An apparatus for applying pressure and high frequency pressure pulsesto the thorax of a person comprising: a garment having an air coreadapted to be located on the thorax of the person for subjecting thethorax of the person to pressure and high frequency pressure pulses, ahousing having an interior enclosed space, an air inlet passage forallowing air to flow into the enclosed space, and an air outlet passagefor allowing air and air pressure pulses to exit from the enclosedspace, a hose member connected to the garment and housing fortransporting air and air pressure pulses from the air outlet passage tothe air core of the garment, a first air displacer located in saidenclosed space, first pivot members pivotally mounting the first airdisplacer on said housing for angular movement in said enclosed space, asecond air displacer located in said enclosed space, second pivotmembers pivotally mounting the second air displacer on said housing forangular movement in said enclosed space, said first and second airdisplacers separating the enclosed space into first, second and thirdchambers, said first and second chambers being open to the air inletpassage for allowing air to flow into the first and second chambers,said third chamber being located between said first and second airdisplacers and open to the air outlet passage for allowing air and airpressure pulses to flow out of the third chamber to the hose memberconnected to the garment and housing, an air flow control valve mountedon each first and second air displacer operable to allow air to flowfrom the first and second chambers into the third chamber and preventair to flow from the third chamber into the first and second chambers, afirst power transmission mechanism located in said first chamber androtatably mounted on the housing operable to angularly move said firstair displacer between first and second positions, a second powertransmission mechanism located in said second chamber and rotatablymounted on the housing operable to angularly move said second airdisplacer between first and second positions, a power transmissionassembly operably connected to the first and second power transmissionmechanisms to concurrently operate the first and second powertransmission mechanisms to angularly move the first and second airdisplacers in opposite directions toward and away from each other todraw air into the first and second chambers and force air through theair flow control valves into the third chamber and expel air and airpressure pulses out of the third chamber for transport into the air coreof the garment, and a motor for driving the power transmission assemblywhereby the first and second power transmission mechanisms angularlymove the first and second displacers in opposite directions toward andaway from each other.
 2. The apparatus of claim 1 wherein: the housingincludes inside walls, the first air displacer has an outer peripheraledge, a first seal mounted on the outer peripheral edge of the first airdisplacer slidably engageable with the inside walls of the housing, thesecond air displacer includes an outer peripheral edge, and a secondseal mounted on the outer peripheral edge of the second air displacerslidably engageable with the inside walls of the housing.
 3. Theapparatus of claim 2 wherein: the outer peripheral edges of the firstand second air displacers include outwardly open grooves, said first andsecond seals comprise ribs and foam material located in said grooves,said foam material biasing the ribs into engagement with said insidewalls of the housing thereby inhibiting air flow between the first andsecond air displacers and the inside walls of the housing.
 4. Theapparatus of claim 1 wherein: the first power transmission mechanismincludes a first arm mounted on the first air displacer, a firstcrankshaft drivably connected to the power transmission assembly, afirst roller mounted on the first crankshaft engageable with the arm,and a second roller mounted on the first crankshaft and located inengagement with the first air displacer, the second power transmissionmechanism includes a second arm mounted on the second air displacer, asecond crankshaft rotatably mounted on the housing and drivablyconnected to the power transmission assembly, a third roller mounted onthe second crankshaft and located in engagement with the second arm, anda fourth roller mounted on the second crankshaft and located inengagement with the second air displacer.
 5. The apparatus of claim 4wherein: the first arm has opposite ends, a pivot member pivotallymounting one end of the first arm on the first air displacer formovement toward and away from the first air displacer, a first membersecured to the first air displacer adjacent to the other end of thefirst arm, a biasing member located between the first member and theother end of the first arm to bias the first arm into engagement withthe first roller, a second arm having opposite ends, a pivot memberpivotally mounting one end of the second arm on the second air displacerfor movement toward and away from the second air displacer, a secondmember secured to the second air displacer adjacent the other end of thefirst arm, a biasing member located between the second member and theother end of the second arm to bias the second arm into engagement withthe third roller.
 6. The apparatus of claim 5 wherein: each biasingmember comprises a spring.
 7. The apparatus of claim 1 including: an airflow restrictor device operable to restrict the flow of air into and outof the first and second chambers to regulate the air pressure generatedby the angularly moving first and second air displacers.
 8. Theapparatus of claim 7 wherein: the air flow restrictor device includes afirst member operable to regulate the flow of air into the first andsecond chambers, and a second member to adjust the location of the firstmember to alter the flow of air into the first and second chambersthereby adjusting the air pressure of the air pulses discharged from thehousing to the air core of the garment.
 9. The apparatus of claim 1wherein: the first and second displacers each include a one-piece rigidmember having a generally flat body having an outer and an inner end,and a convex outer end section joined to the outer end of the body, aridge joined to the inner end of the body, said ridge having oppositeends, and the first and second pivot members comprising cylindricalpivot members joined to the opposite ends of the ridge and extendedoutwardly from the opposite ends of the ridge.
 10. The apparatus ofclaim 9 wherein: the body, convex outer end and ridge include an outerperipheral groove, and at least one seal located in said groove.
 11. Theapparatus of claim 10 wherein: the seal comprises peripheral ribs andfoam material located in said groove, said foam material biasing theribs into engagement with the housing.
 12. The apparatus of claim 9wherein: said ridge includes bosses located adjacent the opposite endsof the ridge, said pivot members being joined to said bosses.
 13. Theapparatus of claim 9 wherein: the body includes at least one hole toallow air to flow through the one-piece rigid member, and said air flowcontrol valve comprising a check valve mounted on the body associatedwith the one hole in the body to allow only one-way flow of air throughthe one-piece rigid member.
 14. An apparatus for applying pressure andhigh frequency pressure pulses to the thorax of a person comprising: agarment having an air core adapted to be located on the thorax of theperson for subjecting the thorax of the person to pressure and highfrequency pressure pulses, a housing having an enclosed space, an airinlet passage to allow air to flow into the enclosed space, and an airoutlet passage to allow air and air pressure pulses to exit from theenclosed space, a hose member connected to the garment and housing fortransporting air and air pressure pulses from the air outlet passage tothe air core of the garment, an air displacer assembly located in saidenclosed space separating the enclosed space into at least one airpumping chamber and an air pulsing chamber, said air displacer assemblyhaving at least one air displacer located between the pumping chamberand pulsing chamber, at least one pivot member pivotally mounting theair displacer on the housing for angular movement between first andsecond positions, an air flow control valve operable to allow air toflow from the pumping chamber into the pulsing chamber and prevent airto flow from the pulsing chamber into the pumping chamber, and a powerdrive system operable to angularly move the air displacer between thefirst and second positions to allow air to flow from the pumping chamberinto the pulsing chamber and prevent air to flow from the pulsingchamber into the pumping chamber.
 15. The apparatus of claim 14 wherein:the power drive system includes a power transmission mechanism rotatablymounted on the housing operable to angularly move the displacer betweensaid first and second positions to draw air into the pumping chamber andforce air and air pulses out of the pulsing chamber into the hosemember, a power transmission assembly operatively connected to the powertransmission mechanism to operate the power transmission mechanism todraw air into the pumping chamber, force air through the air flowcontrol valve into the pulsing chamber, and expel air and air pressurepulses through the air outlet passage out of the pulsing chamber intothe hose member, and a motor for driving the power transmission assemblywhereby the power transmission mechanism angularly moves the displacerbetween said first and second positions.
 16. The apparatus of claim 14wherein: the power drive system includes an anti-backlash deviceoperable without lost motion to angularly move the displacer between thefirst and second positions.
 17. The apparatus of claim 16 wherein: theanti-backlash device includes an arm mounted on the displacer, acrankshaft, a first roller mounted on the crankshaft engageable with thearm, at least one second roller mounted on the crankshaft engageablewith the displacer whereby on rotation of the crankshaft the displaceris angularly moved between said first and second positions.
 18. Theapparatus of claim 17 wherein: the arm has opposite ends, a pivot memberpivotally mounting one end of the arm on the displacer for movementtoward and away from the displacer, a member secured to the displaceradjacent the other end of the arm, and a biasing member located betweenthe member and the other end of the arm to bias the arm into engagementwith the first roller.
 19. The apparatus of claim 18 wherein: thebiasing member is a spring located about the member secured to thedisplacer.
 20. The apparatus of claim 14 including an air flowrestrictor device operable to restrict the flow of air into the pumpingchamber to regulate the air pressure generated by the angularly movingdisplacer.
 21. The apparatus of claim 20 wherein: the air flowrestrictor device includes a first member operable to regulate the flowof air into the pumping chamber, and a second member to adjust thelocation of the first member to alter the flow of air into the pumpingchamber thereby adjusting the air pressure of the air pulses in thepulsing chamber.
 22. The apparatus of claim 14 wherein: the housingincludes inside walls, said displacer has an outer peripheral edge, anda seal mounted on said outer peripheral edge of the displacer slidablyengageable with the inside walls of the housing.
 23. The apparatus ofclaim 22 wherein: the outer peripheral edge of the displacer includes anoutwardly open groove, said seal comprise peripheral ribs and foammaterial located in the groove, said peripheral ribs having surfacesbiased by the foam material into sliding contact with the inside wallsof the housing.
 24. The apparatus of claim 14 wherein: the displacercomprises a one-piece rigid member having a generally flat body havingan outer and an inner end, a convex outer end section joined to theouter end of the body, a ridge joined to the inner end of the body, saidridge having opposite ends, and the at least one pivot member comprisescylindrical pivot members joined to the opposite ends of the ridge andextended outwardly from the opposite ends of the ridge.
 25. Theapparatus of claim 24 wherein: the body, convex outer end and ridgeinclude an outer peripheral groove, and at least one seal located insaid groove.
 26. The apparatus of claim 24 wherein: the seal comprisesperipheral ribs and foam material located in said groove.
 27. Theapparatus of claim 24 wherein: said ridge includes bosses locatedadjacent the opposite ends of the ridge, said pivot members being joinedto said bosses.
 28. The apparatus of claim 24 wherein: the body includesat least one hole to allow air to flow through the one-piece rigidmember, and said air flow control valve comprising a check valve mountedon the body associated with the at least one hole in the body to allowonly one-way flow of air through the one-piece rigid member.
 29. Anapparatus for generating air pulses comprising: a housing having aninterior enclosed space, an air inlet passage for allowing air to flowinto the enclosed space, and an air outlet passage for allowing air andair pulses to exit from the enclosed space, a first air displacerlocated in said enclosed space, at least one first pivot memberpivotally mounting the first air displacer on said housing for angularmovement in said enclosed space, a second air displacer located in saidenclosed space, at least one second pivot member pivotally mounting thesecond air displacer on said housing for angular movement in saidenclosed space, said first and second air displacers separating theenclosed space into first, second and third chambers, said first andsecond chambers being in communication with the air inlet passage forallowing air to flow into the first and second chambers, said thirdchamber being located between said first and second air displacers andin communication with the air outlet passage for allowing air and airpulses to flow out of the third chamber, an air flow control valvemounted on each first and second air displacer operable to allow air toflow from the first and second chambers into the third chamber andprevent air to flow from the third chamber into the first and secondchambers, and a power drive system operable to angularly move the firstand second air displacers to draw air into the first and second chambersand force air into the third chamber and out of the third chamberthrough the air outlet passage.
 30. The apparatus for generating airpulses of claim 29 wherein: the power drive system includes first andsecond power transmission mechanisms mounted on the housing operable toconcurrently angularly move the first and second air displacers inopposite directions toward and away from each other to draw air into thefirst and second chambers and force air through the air flow controlvalves into the third chamber and expel air and air pressure pulsesthrough the air outlet passage out of the third chamber, a powertransmission assembly operably connected to the first and second powertransmission mechanisms to operate the power transmission mechanisms toangularly move the first and second air displacers, and a motor fordriving the power transmission assembly.
 31. The apparatus of claim 29wherein: the housing includes inside walls, the first air displacer hasan outer peripheral edge, a first seal mounted on the outer peripheraledge of the first air displacer slidably engageable with the insidewalls of the housing, the second air displacer includes an outerperipheral edge, and a second seal mounted on the outer peripheral edgeof the second air displacer slidably engageable with the inside walls ofthe housing.
 32. The apparatus of claim 29 wherein: the outer peripheraledges of the first and second air displacers include outwardly opengrooves, said first and second seals comprise ribs and foam materiallocated in said grooves, said foam material biasing the ribs intoslidably engagement with said inside walls of the housing therebyinhibiting air flow between the first and second air displacers and theinside walls of the housing.
 33. The apparatus of claim 29 wherein: thepower drive system includes an anti-backlash device operable withoutlost motion to angularly move the first and second displacers betweenthe first and second positions.
 34. The apparatus of claim 33 wherein:the anti-backlash device includes a first arm mounted on the first airdisplacer, a first crankshaft rotatably mounted on the housing, a firstroller mounted on the first crankshaft engageable with the arm, and asecond roller mounted on the first crankshaft and located in engagementwith the first air displacer, a second arm mounted on the second airdisplacer, a second crankshaft rotatably mounted on the housing, a thirdroller mounted on the second crankshaft and located in engagement withthe second arm, and a fourth roller mounted on the second crankshaft andlocated in engagement with the second air displacer.
 35. The apparatusof claim 34 wherein: the first arm has opposite ends, a pivot memberpivotally mounting one end of the first arm on the first air displacerfor movement toward and away from the first air displacer, a firstmember secured to the first air displacer adjacent to the other end ofthe first arm, a biasing member located between the first member and theother end of the first arm to bias the first arm into engagement withthe first roller, a second arm having opposite ends, a pivot memberpivotally mounting one end of the second arm on the second air displacerfor movement toward and away from the second air displacer, a secondmember secured to the second air displacer adjacent the other end of thefirst arm, a biasing member located between the second member and theother end of the second arm to bias the second arm into engagement withthe third roller.
 36. The apparatus of claim 35 wherein: each biasingmember comprises a spring.
 37. The apparatus of claim 29 including: anair flow restrictor device operable to restrict the flow of air into andout of the first and second chambers to regulate the air pressuregenerated by the angularly moving first and second air displacers. 38.The apparatus of claim 37 wherein: the air flow restrictor deviceincludes a first member operable to regulate the flow of air into thefirst and second chambers, and a second member to adjust the location ofthe first member to alter the flow of air into the first and secondchambers thereby adjusting the air pressure of the air pulses dischargedfrom the housing to the air core of the garment.
 39. The apparatus ofclaim 29 wherein: the first and second displacers each include aone-piece rigid member having a body having an outer end and an innerend, a convex outer end section joined to the outer end of the body, aridge joined to the inner end of the body, said ridge having oppositeends, and the first and second pivot members each comprising cylindricalpivot members joined to the opposite ends of the ridge and extendedoutwardly from the opposite ends of the ridge.
 40. The apparatus ofclaim 39 wherein: the body, convex outer end and ridge include an outerperipheral groove, and at least one seal located in said groove.
 41. Theapparatus of claim 40 wherein: the seal comprises ribs and foam materiallocated in said groove.
 42. The apparatus of claim 39 wherein: saidridge includes bosses located adjacent the opposite ends of the ridge,said pivot members being joined to said bosses.
 43. The apparatus ofclaim 39 wherein: the body includes at least one hole to allow air toflow through the one-piece rigid member, and said air flow control valvecomprising a check valve mounted on the body associated with the onehole in the body to allow only one-way flow of air through the one-piecerigid member.
 44. An apparatus for generating air pressure pulsescomprising: a housing having an enclosed space, and an air inlet passageto allow air to flow into the enclosed space, and an air outlet passageto allow air and air pressure pulses to exit from the enclosed space, anair displacer assembly located in said enclosed space separating theenclosed space into an air pumping chamber and an air pulsing chamber,said air displacer assembly having at least one air displacer locatedbetween the pumping chamber and pulsing chamber, at least one pivotmember pivotally mounting the air displacer on the housing for angularmovement between first and second positions, an air flow control valveoperable to allow air to flow from the pumping chamber into the pulsingchamber and prevent air to flow from the pulsing chamber into thepumping chamber, and a power drive system operable to angularly move theair displacer between the first and second positions to allow air toflow from the pumping chamber into the pulsing chamber and out of thepulsing chamber through the air outlet passage.
 45. The apparatus ofclaim 44 wherein: the air flow control valve is mounted on thedisplacer.
 46. The apparatus of claim 44 wherein: the power drive systemincludes a power transmission mechanism rotatably mounted on the housingoperable to angularly move the displacer between said first and secondpositions to draw air into the pumping chamber and force air and airpulses out of the pulsing chamber, a power transmission assemblyoperatively connected to the power transmission mechanism to operate thepower transmission mechanism to draw air into the pumping chamber, forceair through the air flow control valve into the pulsing chamber, andexpel air and air pressure pulses through the air outlet passage out ofthe pulsing chamber, and a motor for driving the power transmissionassembly whereby the power transmission mechanism angularly moves thedisplacer between said first and second positions.
 47. The apparatus ofclaim 44 wherein: the housing includes inside walls, said displacer hasan outer peripheral edge, and a seal mounted on said outer peripheraledge of the displacer slidably engageable with the inside walls of thehousing.
 48. The apparatus of claim 47 wherein: the outer peripheraledge of the displacer includes an outwardly open groove, said sealcomprise ribs and foam material located in the groove. said foammaterial biasing the ribs into sliding contact with the inside walls ofthe housing.
 49. The apparatus of claim 44 wherein: the power drivesystem includes an anti-backlash device operable without lost motion toangularly move the at least one displacer between first and secondpositions.
 50. The apparatus of claim 49 wherein: the anti-backlashdevice includes an arm mounted on the displacer, a crankshaft rotatablymounted on the housing, a first roller mounted on the crankshaftengageable with the arm, at least one second roller mounted on thecrankshaft engageable with the displacer whereby on rotation of thecrankshaft the displacer is angularly moved between said first andsecond positions.
 51. The apparatus of claim 50 wherein: the arm hasopposite ends, a pivot member pivotally mounting one end of the arm onthe displacer for movement toward and away from the displacer, a membersecured to the displacer adjacent the other end of the arm, and a abiasing member located between the member and the other end of the armto bias the arm into engagement with the first roller.
 52. The apparatusof claim 51 wherein: the biasing member is a spring located about themember secured to the displacer.
 53. The apparatus of claim 44 includingan air flow restrictor device operable to restrict the flow of air intothe pumping chamber to regulate the air pressure generated by theangularly moving displacer.
 54. The apparatus of claim 53 wherein: theair flow restrictor device includes a first member operable to regulatethe flow of air into the pumping chamber, and a second member to adjustthe location of the first member to alter the flow of air into thepumping chamber thereby adjusting the air pressure of the air pluses inthe pulsing chamber.
 55. The apparatus of claim 44 wherein: thedisplacer comprises a one-piece rigid member having a generally flatbody having an outer end and an inner end, a convex outer end sectionjoined to the outer end of the body, a ridge joined the inner end of thebody, said ridge having opposite ends, and the first and second pivotmembers comprising cylindrical pivot members joined to the opposite endsof the ridge and extended outwardly from the opposite ends of the ridge.56. The apparatus of claim 55 wherein: the body, convex outer end andridge include an outer peripheral groove, and at least one seal locatedin said groove.
 57. The apparatus of claim 56 wherein: the sealcomprises ribs and foam material located in said groove.
 58. Theapparatus of claim 44 wherein: said ridge member includes bosses locatedadjacent the opposite ends of the ridge member, said pivot members beingjoined to said bosses.
 59. The apparatus of claim 44 wherein: the bodyincludes at least one hole to allow air to flow through the one-piecerigid member, and said air flow control valve comprising a check valvemounted on the body associated with the one hole in the body to allowonly one-way flow of air through the one-piece rigid member.
 60. An airdisplacer for an apparatus for generating air pressure pulsescomprising: a one-piece rigid member having a body having an outer endand an inner end, a convex outer end section joined to the outer end ofthe body, a ridge joined to the inner end of the body, said ridge havingopposite ends, and cylindrical pivot members joined to the opposite endsof the ridge and extended outwardly from the opposite ends of the ridge.61. The air displacer of claim 60 wherein: the body, convex outer endand ridge include an outer peripheral groove, and at least one seallocated in said groove.
 62. The air displacer of claim 61 wherein: theseal comprises ribs and foam material located in said groove.
 63. Theair displacer of claim 60 wherein: said ridge includes bosses locatedadjacent the opposite ends of the ridge, said pivot members being joinedto said bosses.
 64. The air displacer of claim 60 wherein: the memberincludes at least one hole to allow air to flow through the member, anda check valve mounted on the body associated with the one hole in thebody to allow only one-way flow of air through the member.
 65. A methodof applying pressure pulsing forces to the thorax of a person with agarment having an air core connected with a hose to an apparatus forgenerating air pressure pulses having first and second air displacerspivotally mounted on a housing for angular movements between first andsecond positions to separate an air pulsing chamber from first andsecond air pumping chambers and an air flow control valve forcontrolling the flow of air from the pumping chambers into the airpulsing chamber characterized by: locating the garment around the thoraxof a person, angularly moving the first and second air displacers towardand away from each other relative to the air pulsing chamber and thefirst and second pumping chambers to cause air to flow into the firstand second pumping chambers, through the air flow control valves andinto the air pulsing chamber, regulating the flow of air into the firstand second pumping chambers during angular movements of the first andsecond air displacers to regulate the pressure of the air in the firstand second pumping chambers and the air pulsing chamber, and regulatingthe angular movements of the first and second air displacers to adjustthe frequency of the air pressure pulses in the air pulsing chamber andair core of the garment thereby regulating the frequency of the pressurepulses applied to the thorax of the person.
 66. The method of claim 65including: adjusting the rate of the flow of air into the first andsecond pumping chambers to change the pressure of the air in the firstand second air pumping chambers and air pulsing chamber.
 67. The methodof claim 65 wherein: the regulation of the angular movements of thefirst and second air displacers is achieved by changing the speed of theangular movements of the first and second air displacers.
 68. The methodof claim 65 including: adjusting the rate of the flow of air into thefirst and second pumping chambers to change the pressure of the air inthe first and second pumping chambers and air pulsing chamber, andchanging the speed of the angular movements of the first and second airdisplacers to regulate the angular movements of the first and second airdisplacers.
 69. A method of applying pressure pulsing forces to thethorax of a person with a garment having an air core connected with ahose to an apparatus for generating air pressure pulses having at leastone air displacer pivotally mounted on a housing for angular movementbetween first and second positions to separate an air pulsing chamberfrom an air pumping chamber and an air flow control valve forcontrolling the flow of air from the pumping chamber into the airpulsing chamber characterized by: locating the garment around the thoraxof a person, angularly moving the air displacer relative to the airpumping chamber and air pulsing chamber to cause air to flow into thepumping chamber and through the air flow control valve and into thepulsing chamber, regulating the flow of air into the pumping chamberduring angular movement of the air displacer between the first andsecond positions to regulate the pressure of the air in the pumpingchamber and air pulsing chamber, and regulating the angular movement ofthe air displacer to adjust the frequency of the pressure pulses appliedto the thorax of the person.
 70. The method of claim 69 including:adjusting the rate of the flow of air into the pumping chamber to changethe pressure of the air in the air pumping chamber and air pulsingchamber.
 71. The method of claim 69 including: changing the speed of theangular movement of the air displacer to regulate the angular movementof the air displacer to adjust the frequency of the pressure pulsesapplied to the thorax of the person.
 72. The method of claim 69including: adjusting the rate of the flow of air into the pumpingchamber to change the pressure of the air in the air pumping chamber andair pulsing chamber, and changing the speed of the angular movement ofthe air displacer to regulate the angular movement of the air displacerto adjust the frequency of the pressure pulse applied to the thorax ofthe person.
 73. An apparatus for applying pressure and high frequencypressure pulses to the thorax of a person comprising: a garment havingan air core adapted to be located on the thorax of the person forsubjecting the thorax of the person to pressure and high frequencypressure pulses, a housing having an interior enclosed space, an airinlet passage for allowing air to flow into the enclosed space, and anair outlet passage for allowing air and air pressure pulses to exit fromthe enclosed space, a hose member connected to the garment and housingfor transporting air and air pressure pulses from the air outlet passageto the air core of the garment, a first air displacer located in saidenclosed space, at least one first pivot member pivotally mounting thefirst air displacer on said housing for angular movement in saidenclosed space, a second air displacer located in said enclosed space,at least one second pivot member pivotally mounting the second airdisplacer on said housing for angular movement in said enclosed space,said first and second air displacers separating the enclosed space intofirst, second and third chambers, said first and second chambers beingopen to the air inlet passage for allowing air to flow into the firstand second chambers, said third chamber being located between said firstand second air displacers and open to the air outlet passage forallowing air and air pressure pulses to flow out of the third chamber tothe house member connected to the garment and housing, at least one airflow control valve operable to allow air to flow from the first andsecond chambers into the third chamber and prevent air to flow from thethird chamber into the first and second chambers, and a power drivesystem operable to angularly move the first and second air displacers todraw air into the first and second chambers and force air through theair flow control valves into the third chamber and out of the thirdchamber into the hose member.
 74. The apparatus of claim 73 wherein: thepower drive system includes a first power transmission mechanism locatedin said first chamber and rotatably mounted on the housing operable toangularly move said first air displacer between first and secondpositions, a second power transmission mechanism located in said secondchamber and rotatably mounted on the housing operable to angularly movesaid second air displacer between first and second positions, a powertransmission assembly operably connected to the first and second powertransmission mechanisms to concurrently operate the first and secondpower transmission mechanisms to angularly move the first and second airdisplacers in opposite directions toward and away from each other todraw air into the first and second chambers and force air through theair flow control valves into the third chamber and expel air and airpressure pulses out of the third chamber for transport into the air coreof the garment, and a motor for driving the power transmission assemblywhereby the first and second power transmission mechanisms angularlymove the first and second displacers in opposite directions toward andaway from each other.
 75. The apparatus of claim 73 wherein: the powerdrive system includes an anti-backlash device operable without lostmotion to angularly move the first and second displacers between thefirst and second positions.
 76. The apparatus of claim 75 wherein: theanti-backlash device includes a first arm mounted on the first airdisplacer, a first crankshaft rotatably mounted on the housing, a firstroller mounted on the first crankshaft engageable with the arm, and asecond roller mounted on the first crankshaft and located in engagementwith the first air displacer, a second arm mounted on the second airdisplacer, a second crankshaft rotatably mounted on the housing, a thirdroller mounted on the second crankshaft and located in engagement withthe second arm, and a fourth roller mounted on the second crankshaft andlocated in engagement with the second air displacer.
 77. The apparatusof claim 76 wherein: the first arm has opposite ends, a pivot memberpivotally mounting one end of the first arm on the first air displacerfor movement toward and away from the first air displacer, a firstmember secured to the first air displacer adjacent to the other end ofthe first arm, a biasing member located between the first member and theother end of the first arm to bias the first arm into engagement withthe first roller, a second arm having opposite ends, a pivot memberpivotally mounting one end of the second arm on the second air displacerfor movement toward and away from the second air displacer, a secondmember secured to the second air displacer adjacent the other end of thefirst arm, a biasing member located between the second member and theother end of the second arm to bias the second arm into engagement withthe third roller.
 78. The apparatus of claim 77 wherein: each biasingmember comprises a spring.
 79. The apparatus of claim 73 including: anair flow restrictor device operable to restrict the flow of air into andout of the first and second chambers to regulate the air pressuregenerated by the angularly moving first and second air displacers. 80.The apparatus of claim 79 wherein: the air flow restrictor deviceincludes a first member operable to regulate the flow of air into thefirst and second chambers, and a second member to adjust the location ofthe first member to alter the flow of air into the first and secondchambers thereby adjusting the air pressure of the air pulses dischargedfrom the housing to the air core of the garment.